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    Skills Alliance is recruiting on behalf of a global engineering consultancy that focuses on life science compliance projects. In Switzerland, our client has multiple projects running with large bio-pharmaceutical companies in the German speaking cantons. On our client’s behalf, we’re recruiting for an engineering consultant that will represent our client at a manufacturing site in Bern and act as a Process Validation Engineer.

    Responsibilities:

    • Plan, Coordinate and execute all phases for validation of processes and supporting validation activities (i.e. cleaning validation, cleaning verification, mixing validation etc.)
    • Prepare and review (validation plans, minutes, reports) GMP related documentation
    • Bridging with cross-functional teams handling validation activities
    • Operational handling of Change Controls, CAPAs and Non-Conformances related to process validation and supporting validation activities
    • Perform risk/criticality assessments

    Requirements:

    • Bachelor/Master Degree in technical or natural sciences
    • A minimum of 3 years of working experience within a pharma or a biotech company
    • Basic Know-how of biotechnology processes
    • Profound Know-how of Validation requirements according to cGMP
    • Experience in process validation is a must
    • Experience in cleaning validation is an asset
    • Know-how of quality assurance principles
    • Flexibility to travel across Switzerland
    • Fluency in English and minimum B2 level German

    Due to the nature of this role, our client is only considering applicants already residing in Switzerland.

    By joining our client’s consultancy, you will be provided with a permanent contract and will be compensated separately for overtime spent on their projects. Travel expenses and long commutes are also compensated.

    If you would like to know more about this vacancy and our client, please get in touch with Khephren Mongongu +41 43 508 29 16 or click apply. We’re looking forward to your application.

  • $150000 - $160000 per annum, Target Bonus – 5%-10%,Medical, Dental, Vision, Life insurance & 401(K)
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    Regulatory Affairs Strategy is a key area for an exclusive client of ours in New Jersey, actively hiring this pivotal role.

    Our client is a market leading specialty pharmaceutical company who develop innovative products in both the injectable and ophthalmic space.

    Regulatory Affairs are a key aspect for our client who are dedicated to the development of enhanced products that address unmet clinical and/or commercial needs of current FDA approved molecules.

    As Regulatory Affairs, Senior Manager 2 you will lead regulatory activities for assigned products including:

    • Development of product regulatory strategy
    • Advise the product team on development activities
    • Lead the development and/or review of submission documentation
    • Address Health Authority (HA) requests and drive HA responses

    As Regulatory Affairs, Senior Manager 2 you will have an influential role improving the development cycle timelines and regulatory processes.

    Key responsibilities:

    • Regulatory Strategy Development
    • Regulatory Documentation
    • Regulatory Submissions (IND/NDA)
    • Interfacing with Authorities

    As Regulatory Affairs, Senior Manager 2 you are expected to have experience in new drug regulated product strategy and submissions plus the development and preparation of successful regulatory submissions.

    Our client will begin initial phone screens next week and offer a competitive base salary and benefits.

    If you have suitable experience and are open to an initial confidential discussion, please apply with your latest Resume for a prompt response.

  • UK

    £55000 - £65000 per annum
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    Medical Device Quality Manager

    Would you be interested in working with a leading pharmaceutical company as a Medical Device Quality Manager based in West London?

    Now onto a little about the opportunity itself; You would be joining a company with a strong EU presence and an impressive portfolio of devices currently in the pipeline. The role requires an experienced manager with a background in medical device quality systems to develop the quality function and liaise with other directors and board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Acting as a leader of global quality to ensure MDQMS are up to date
    • Coordinating all the processes related to the Medical Device quality system
    • Performing audits in line with ISO 13485
    • Opportunity to support the wider Quality function

    Requirements:

    • Experience at managerial level
    • Experience within medical device auditing
    • An engineering degree or equivalent
    • Strong analytical and communication skills

    This Medical Device Quality Manager role is an office-based position in London. It is a permanent role offering an attractive package, which can be discussed further on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

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    Skills Alliance is currently partnered with a leading Biopharmaceutical company based in the Northern part of Switzerland that is looking for a Scientific Associate to join their team on a 12-month rolling contract.

    The successful candidate will have the following responsibilities:

    • Define the equipment required for each of the test methods, procure and qualify equipment including protocols and reports writing.
    • Create the equipment calibration and maintenance plan.
    • Develop test methods required by product functions to test.
    • Procure and control test method fixture to requirement
    • Create test method validation protocol and acceptance criteria, procure tests parts, execute test method validation and write associated report.
    • Transfer method from/with suppliers including equivalency tests method statistical criteria for qualification and validation and execute transfer.
    • Write test method instructions.
    • Manage Product storage and pre-conditioning required prior to testing
    • Perform all functional test internally and support testing with service Providers for sub-contracted tests
    • Complete statistical analysis to acceptance criteria and write reports.
    • Create and maintain a laboratory notebook and ensure raw data integrity and accuracy using a four-eyes principle. Analyze any test failure, demonstrating if it is test method related or product related.
    • Collaborate pro-actively with technical experts for investigations and resolution.

    Should you be interested in finding out more about this opportunity, please contact me on: +41 43 508 21 04 or submit your application online.

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    Skills Alliance is currently partnered with a leading Biopharmaceutical company based in the Northern part of Switzerland that is looking for a Senior Manager Analytical Development & Quality Control to join their team on a 12-month rolling contract.

    The successful candidate will have the following qualifications/responsibilities:

    • Minimum 3 – 5 years of GMP experience in pharmaceutical industry in analytical development and quality control.
    • Supervision of analytical method validations (creation and/or review of validation protocols and reports)
    • Supervision of analytical method development (e.g. HPLC / GC)
    • Planning and supervision of method transfers
    • Set up of specifications and stability protocols for drug substance
    • Evaluation of stability reports including investigation of results (OOS / OOE / OOT)
    • Giving support for writing of regulatory documents
    • Very good knowledge in HPLC
    • Knowledge in HRMS and NMR is beneficial
    • Experience in late Phase or Commercial Phase Projects would be a plus
    • Good Project Management skills
    • Experience with external CMO’s would be beneficial
    • English business fluency and Chinese advantageous

    Should you be interested in this opportunity, please contact Egi Bendo at +41 43 508 21 04 or submit your application online.

  • UK

    Generous salary + bonus + extensive benefits
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    My client is an exciting global pharmaceutical company recruiting for a CTA role within their Neuroscience division. This is an excellent opportunity to join a world-class pharma company with a very strong reputation in the industry and a good pipeline. We have got good feedback from people we have placed there recently. Their team is dynamic and works on a global basis. They offer good long-term prospects.

    This is a permanent, full-time role based just North of London but they may offer some flexibility to work from home after a short time.
    They are offering a generous salary plus bonus and extensive benefits

    Key requirements

    • eTMF experience
    • Proficiency in Microsoft Package
    • Life Science degree
    • Previous experience in Clinical is desirable

    If you would like to apply and hear more about this opportunity then please call Arturo Maldonado on 02036683963

  • UK

    £40000 - £60000 per annum
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    A global Biopharmaceutical Medical Device company are recruiting for a Senior Regulatory Affair Associate position with managerial responsibilities based in Kent.

    This is an opportunity to be a part of a growing and highly ranked Biopharma in its industry whom are continuing to expand in the UK and Europe. As expansion continues, career progression and development opportunities increase. Their product line is expanding and encompassing the dental and cosmetic areas.

    Responsibilities:

    • Technical file compilation and maintenance and filling of necessary applications for market entry
    • Build product line and register them globally
    • Ensure any regulatory changes affecting the domestic and global distribution of private label products are managed effectively
    • Develop Regulatory strategy for private labelled medical device and cosmetic product to ensure compliance in line with applicable country requirements

    Requirements:

    • 4-5 years of Regulatory Affairs and Quality Systems experience in the medical device industry
    • Managing compliance to/working within ISO 9001 and ISO 13845 quality management system and performing audits
    • Compilation and Maintenance of EU Technical Files and documentation
    • Effectively managing staff, processes, and technology
    • Knowledge of MDD and MDR
    • This role has a level of skill commensurate with a tertiary degree preferably in a scientific/technical/medical discipline or a related field

    This Regulatory Affair Associate is an office-based position in Kent. It Is a permanent role offering around £40-60K + bonus + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details click APPLY NOW

  • UK

    Competitive salary and car allowance
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    My client is an international CRO looking for a Senior CRA to join their exciting Clinical team. The company offers a full in-house service to their clients and has expertise in all drug types, dosage forms and delivery mechanisms. They specialise in a number of interesting therapeutic areas such as Oncology and Rare and Orphan diseases.

    This is a full-time permanent role based in-house and purely focused on monitoring responsibilities on a nationwide scale. There are no submission responsibilities involved such as feasibility, so this might be of interest to those who enjoy monitoring aspects.

    The Director of Clinical is looking to realign and grow his team, so eventually monitoring will change from national to regional, meaning less travel.

    Key responsibilities:

    • Monitoring of clinical studies of new and established pharmaceuticals
    • Ensuring projects are conducted in accordance with company SOPs and ICH guidelines
    • Obtaining and maintaining project documentation
    • Managing of other CRAs including mentoring and supervision

    Key Requirements:

    • 5 years monitoring experience in clinical research for CRO, pharma or biotech
    • IMP Trial experience
    • Strong Oncology background/experience preferable
    • Knowledge of ICH-GCP
    • Life Science degree


    If you are interested in this opportunity to join a fast-growing and international organisation then please apply now.
    Alternatively, contact Arturo Maldonado on 0203 668 3963 to discuss further.

  • USA

    Competitive Pay + Benefits
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    We are partnered with a Companion Diagnostic Company in Seattle that is transforming care for cancer patients by providing genomic analysis of the disease using non-invasive liquid biopsy methods. Their assay platform has been validated to detect all four major types of genetic alterations that cause cancer! They are seeking an experienced Senior Full Stack Engineer for their team. You’ll be architecting and developing essential software systems that support the IVD development and local R&D projects, as well as facilitate integration with clients and research partners. This is a great opportunity to work for an exciting growing company who will truly make an impact in people’s lives.

    • 5+ years professional experience in software development

    • Experience gathering requirements and user acceptance required

    • React and/or React Native based development

    • Full stack development in a serverless environment using AWS, AWS core services

    • REST API design and development using Node.JS Express

    • Git / GitHub Flow

    • TDD

    • Kanban and/or SCRUM type practice, Jira/Trello

    • Ubuntu / Amazon Linux flavorings

    We are moving quickly on this position so do not hesitate to apply!

  • £85000 - £95000 per annum, car allowance + bonus
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    Senior Medical Advisor – Growing Portfolio

    Our client, a globally renowned pharmaceutical company, are currently looking for experienced Medical Advisors to join their medical team as a Senior Medical Advisor.

    This company have a growing cardiovascular therapeutic area and so have a growing team. With 2 medical advisors already in this team, they are looking for a Senior Medical Advisor to come on board to be the right-hand person to the Medical Director as well as working closely with the medical advisors and any other junior members of the team.

    As part of this role, you will be working with a growing product portfolio of established products, as well as working on the product launch of a new addition to the portfolio.

    The role covers the UK and Ireland, and a large part of the role will include final signatory. With this in mind, our client is looking for either a qualified pharmacist or medic with medical advisor experience and ideally at least a year of experience with medical final signatory.

    This is a great opportunity for anyone looking to take the next step in their career and move into a more senior role, taking on more responsibility. Our client is a mid-sized pharmaceutial company who are growing and building teams in other therapeutic areas too, so there’s plenty of opportunity for progression within the company once you join.

    If you’re looking to join a company where work-life balance is important, alongside working for a globally renowned company this could be the role for you!

    For more information on this position or any similar opportunities, please get in touch with Chanel Hicken on 0207 220 6206. Alternatively, please email me your CV and we can arrange a time for a confidential discussion on how to progress your career.

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    JOB TITLE: Clinical Pharmacologist

    An emerging Biotech company is seeking an experienced Clinical Pharmacologist to join their rapidly growing R&D team. You will have the responsibility and accountability for clinical Pharmacology programs within the Oncology space to contributing significantly to the growth of the company.

    Company Overview:

    An Emerging Biotech company aiming at development of novel small molecule cancer therapeutics. It is one of the largest drug discovery companies in Europe and aims to develop breakthrough therapies in Oncology. The company has a stronghold of over 500 scientists and is partnered with both large and medium sized companies in the US and Europe.

    Responsibilities

    • Leading complex Pharmacology studies
    • Providing leadership and accountability for Clinical Pharmacology Phase 1-4 clinical development programs
    • Develops PK/PD modelling and stimulation plans
    • Accountable for appropriate design and implementation of clinical modelling, simulation plan and interpreting results.
    • Oversees PK and PK/PD insight, biomarker and efficacious dose prediction strategies
    • Contribute to the development of clinical study concepts and protocols, clinical study reports and relevant components of regulatory submission documents and publications
    • Provide a source of Pharmacology expertise and advice to other functions across the company
    • Work collaboratively with the global teams

    Requirements:

    • Advanced degree (PhD, MD or PharmD) in Pharmacology, pharmaceutical Sciences, Pharmacy or related field
    • Minimum 5 Years experience in Clinical Pharmacology for Biotech/Pharmaceutical company
    • Proven track record of experience in PK/PD and application models
    • Understanding of regulatory guidance related to Clinical Pharmacology
    • Good understanding og clinical drug development and the overall R&D process is required
    • Experience working on small molecules
    • Experience working on Oncology, Immuno-oncology or hematology programs
    • Experience working on programs Phase I-IV

    Benefits:

    • Competitive salary and Bonus scheme
    • Private medical Health Insurance
    • Flexible working hours with option of work from home days

    Apply:
    Please apply directly or send an email to natalia.k.a4lgdx1gtoze@skillsalliance.aptrack.co

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    Skills Alliance is partnered with a multinational company, which provides clinical research services to the pharmaceutical and medical device industry globally. They are looking for a Freelance Clinical Submission Specialist to be based anywhere within the UK. For this purpose, we are currently supporting our client with their search.

    Location: UK (home-based)

    Duration: 6-12 months

    Job Type: Freelance Contract

    Essential Duties & Responsibilities:

    • Prepare, review, and coordinate local submissions to Regulatory and Ethics Committee required for clinical trial site approval.
    • Prepare country/site-specific patient informed consent form according to regulatory and EC requirements.
    • Provide local regulatory strategy and advice.
    • Act as the main point of contact of EC.
    • Provide support to and work in close cooperation with Clinical Affairs and Clinical Operations teams.

    Education/Experience/Skills:

    • University degree in health/life science-related field
    • Highly experienced in EC submission
    • Previous experience in clinical studies as clinical research associate, clinical assistant/specialist in pharmaceutical industry, CRO, medical device, or biotech company
    • Fluent in English
    • Proficient in operating a PC and using various PC-based software packages including Microsoft Word and Excel
    • Excellent communication, organizational, and time management skills

    If you would like to discuss this vacancy further, please contact Egi Bendo at +41 43 508 21 04.

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    Skills Alliance is currently partnered with a leading medical device company based in western Germany . For this purpose, our client is looking for a Device Support Specialist/Application Consultant in Outpatient Care to join their team. This is a Permanent/Full time opportunity.

    **Anyone with Nursing background and healthcare industry who is looking to move into a corporate enviornment with a flexibility of WFH, no night shifts are very welcome to apply**

    *You must be proficient in German and English*

    Your responsibilities:-

    · Conducting patient and relatives training or retraining on medical devices from Novocure
    · Regular check of the correct application and function of the device on site at the patient
    · Independent solving of technical and application-related difficulties. Here you can count on the support of a specialist team
    · Independent planning and organization of your appointments and the associated administration
    · Care of a patient strain in a larger radius (200-300km). Flexibility to help out in other regions in the short term

    Our requirements:-

    · Completed training in the medical-nursing field
    · Experience in dealing with people in difficult situations
    · Safe handling of modern means of communication, MS Office, as well as the willingness to become familiar with other software programs
    · A valid Class B driving license
    · Ideally, first experiences in field service
    · Very good German and good English skills (as a minimum B2 level)

    If you would like to discuss this opportunity further, please contact Heena Verma at +41 44 798 2410.

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    Skills Alliance is currently partnered with a leading medical device company based in German part of Switzerland. For this purpose, our client is looking for a Clinical Safety Specialist to join their team. This is a Permanent/Full time opportunity.

    In this role you will be responsible for to implement and oversee all areas of safety monitoring and reporting for clinical trials.

    Your responsibilities:

    · Process, assess and critically review adverse event data.
    · Maintenance of safety report database
    · Prepare periodic safety reports
    · Respond to regulatory safety queries
    · Interface with Contract Research Organizations (CROs), project team members and clinical trial sites
    · Train others on safety related topics internally and externally
    · Support the development of safety monitoring plans for the clinical trials
    · Ensure activities comply with the applicable Quality System requirements

    Your profile:

    · Bachelor’s level degree preferably in nursing, pharmacy or other health related profession, or degree as Registered Nurse/ Medical Doctor
    · Minimum of 3 year active clinical experience or 2 years of medical device/drug safety-related experience in multinational clinical trials
    · Familiarity with regulatory affairs in Europe and North America and experience in clinical research in oncology
    · Understanding of European and North American regulatory systems for clinical trials
    · Accredited GCP course is a plus
    · Fluency in English (verbal and written), an additional European languages is preferred


    If you would like to discuss this opportunity further, please contact Heena Verma at +41 44 798 2410.

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    Skills Alliance is partnered with a global medical device company that is very active within the Oncology field. To complement their team in the North Rhine-Westphalia region, our client will be looking for an Application Consultant in Outpatient Patient Care/Device Support Specialist. This would be a good opportunity for candidates with a nursing background within a hospital environment, who are looking to make a move into a rather corporate environment. No night shifts are required for this position!

    Employment Type: Full-time, Permanent
    Location: North-Rhine Westphalia
    Language Requirements: English and German

    Anwendungsberater/in in der ambulanten Patientenbetreuung
    (Spezialist für Geräteunterstützung)

    Essential Duties & Responsibilities:

    • Durchführen von Patienten- und Angehörigenschulungen bzw. Nachschulungen an medizintechnischen Geräten
    • Regelmässiges Überprüfen der korrekten Anwendung und Funktion des Gerätes vor Ort bei den Patienten
    • Selbstständiges Lösen von technischen und anwendungsbedingten Schwierigkeiten.
    • Eigenständige Planung und Organisation Ihrer Termine und der dazugehörigen Administration
    • Betreuung eines Patientenstamms in einem grösseren Umkreis.

    Education/Experience/Skills:

    • Abgeschlossene Ausbildung im medizinisch-pflegerischen Bereich
    • Erfahrung im Umgang mit Menschen in schwierigen Situationen
    • Sichere Handhabung von modernen Kommunikationsmitteln, MS Office, sowie die Bereitschaft, sich in andere Software Programme einzuarbeiten
    • Eine gültige Fahrerlaubnis Klasse B
    • Idealerweise erste Erfahrungen im Aussendienst
    • Sehr gute Deutsch- und gute Englisch-Kenntnisse (als Minimum B2 Level)

    If you would like to discuss this vacancy further please call Egi Bendo at +41 43 508 21 04.

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    A Leading global Biopharmaceutical company are recruiting for a Regulatory Affairs Manager position based in the Benelux region.

    This is an opportunity to be a part a growing International Regulatory Affairs team that are paving a new way to develop medications to deliver to patients across the globe. The rapid growth of the company is accompanied by excellent career progression opportunities.

    Responsibilities:

    • Review the draft guideline for EU and provide the comments on the draft guidance for EU environment shaping
    • Sensing the EU regulatory change/trend and collect the regulatory intelligence and update the EU regulatory environment change
    • Develop EU specific SOPs and manuals in line with EU regulation/guidance and internal process
    • Provide regulatory strategies, risks and mitigations
    • Act as a local representative for clinical trial application in EU
    • CRO management on regulatory compliance submission (e.g. PSUR submission, pharmacovigilance)
    • Manage/support the regulatory procedure/document preparation including MAA, post-approval activities (e.g. EU document request, CPP request, legalisation, notarisation etc.)
    • Draft final labelling/artwork components for regulatory submissions/commercial purpose

    Requirements:

    • At least 4 years’ experience in relevant fields
    • Good breadth of understanding of the European regulations
    • Project management experience is preferred
    • A Bachelor’s degree in science or related fields

    This Regulatory Affair Manager position comes with a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details click APPLY NOW

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    Skills Alliance is currently partnered with a leading medical device company based in German part of Switzerland. For this purpose, our client is looking for a Clinical Safety Specialist to join their team. This is a Permanent/Full time opportunity.

    In this role you will be responsible for to implement and oversee all areas of safety monitoring and reporting for clinical trials.

    Your responsibilities:

    · Process, assess and critically review adverse event data.
    · Maintenance of safety report database
    · Prepare periodic safety reports
    · Respond to regulatory safety queries
    · Interface with Contract Research Organizations (CROs), project team members and clinical trial sites
    · Train others on safety related topics internally and externally
    · Support the development of safety monitoring plans for the clinical trials
    · Ensure activities comply with the applicable Quality System requirements

    Your profile:

    · Bachelor’s level degree preferably in nursing, pharmacy or other health related profession, or degree as Registered Nurse/ Medical Doctor
    · Minimum of 3 year active clinical experience or 2 years of medical device/drug safety-related experience in multinational clinical trials
    · Familiarity with regulatory affairs in Europe and North America and experience in clinical research in oncology
    · Understanding of European and North American regulatory systems for clinical trials
    · Accredited GCP course is a plus
    · Fluency in English (verbal and written), an additional European languages is preferred


    If you would like to discuss this opportunity further, please contact Heena Verma at +41 44 798 2410.

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    Skills Alliance is currently partnered with a leading medical device company based in western Germany . For this purpose, our client is looking for a Device Support Specialist/Application Consultant in Outpatient Care to join their team. This is a Permanent/Full time opportunity.

    **Anyone with Nursing background and healthcare industry who is looking to move into a corporate enviornment with a flexibility of WFH, no night shifts plus Company car **

    *You must be proficient in German and English*
    You must hold a valid Driving licence

    Your responsibilities:-

    · Conducting patient and relatives training or retraining on medical devices from Novocure
    · Regular check of the correct application and function of the device on site at the patient
    · Independent solving of technical and application-related difficulties. Here you can count on the support of a specialist team
    · Independent planning and organization of your appointments and the associated administration
    · Care of a patient strain in a larger radius (200-300km). Flexibility to help out in other regions in the short term

    Our requirements:-

    · Completed training in the medical-nursing field
    · Experience in dealing with people in difficult situations
    · Safe handling of modern means of communication, MS Office, as well as the willingness to become familiar with other software programs
    · A valid Class B driving license
    · Ideally, first experiences in field service
    · Very good German and good English skills (as a minimum B2 level)

    If you would like to discuss this opportunity further, please contact Heena Verma at +41 44 798 2410.

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    Skills Alliance is currently partnered with a leading medical device company based in western Germany . For this purpose, our client is looking for a Device Support Specialist/Application Consultant in Outpatient Care to join their team. This is a Permanent/Full time opportunity.

    This is a HOME-BASED ROLE and you would visit with an equipment/device to patients home in the Siegen region, Germany.

    **Anyone with Nursing background and healthcare industry who is looking to move into a corporate enviornment with a flexibility of WFH, no night shifts plus Company car **

    *You must be proficient in German and English*
    You must hold a valid Driving licence

    Your responsibilities:-

    · Conducting patient and relatives training or retraining on medical devices from Novocure
    · Regular check of the correct application and function of the device on site at the patient
    · Independent solving of technical and application-related difficulties. Here you can count on the support of a specialist team
    · Independent planning and organization of your appointments and the associated administration
    · Care of a patient strain in a larger radius (200-300km). Flexibility to help out in other regions in the short term

    Our requirements:-

    · Completed training in the medical-nursing field
    · Experience in dealing with people in difficult situations
    · Safe handling of modern means of communication, MS Office, as well as the willingness to become familiar with other software programs
    · A valid Class B driving license
    · Ideally, first experiences in field service
    · Very good German and good English skills (as a minimum B2 level)

    If you would like to discuss this opportunity further, please contact Heena Verma at +41 44 798 2410.

  • UK

    £35000 - £55000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    Quality & Regulatory Manager

    A rare opportunity for an experienced Quality and Regulatory Affairs Manager to join a global distributor of medical products and services with presence in more than 30 countries, making it a truly global organisation.

    Together with the Quality & Regulatory Director and the UK team, as a Quality & Regulatory Manager you will develop and manage present and future business activities as well as conducting the company’s private range of medical products in conformity with relevant requirements. As part of this company, you will have the opportunity to enhance your skillset while gaining international exposure and working alongside leading specialists in the industry.

    Responsibilities:

    • Manage QMS processes and any required documentation
    • Coordinate and conduct inspections of the company and its suppliers
    • Oversee the quality and environmental training
    • Ensure a clear communication between the Regulatory and Quality departments

    Requirements:

    • Approximately 4 years of Quality and Regulatory experience focusing in the medical device industry
    • Experience working within ISO 9901, ISO 13485 and ISO 14001
    • Knowledge of working within GMP/ GDP requirements
    • Excellent written and communication skills

    This is a permanent and full-time position offering a competitive salary between 35K-55K; this can be discussed further on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    £55000 - £65000 per annum
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    Medical Device Quality Manager

    Would you be interested in working with a leading pharmaceutical company as a Medical Device Quality Manager based in West London?

    Now onto a little about the opportunity itself; You would be joining a company with a strong EU presence and an impressive portfolio of devices currently in the pipeline. The role requires an experienced manager with a background in medical device quality systems to develop the quality function and liaise with other directors and board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Acting as a leader of global quality to ensure MDQMS are up to date
    • Coordinating all the processes related to the Medical Device quality system
    • Performing audits in line with ISO 13485
    • Opportunity to support the wider Quality function

    Requirements:

    • Experience at managerial level
    • Experience within medical device auditing
    • An engineering degree or equivalent
    • Strong analytical and communication skills

    This Medical Device Quality Manager role is an office-based position in London. It is a permanent role offering an attractive package, which can be discussed further on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    Competitive salary + bonus + extensive benefits
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    A Global Pharmaceutical company is looking for a Study Manager to join their exciting Infectious Diseases division. This is an excellent opportunity to join a leading organisation in clinical operations with a clear and strong vision to advance therapeutics against life-threatening diseases. In addition, they have a very strong pipeline across a range of therapy areas

    Although an already established name in the industry, they are expanding and there will be excellent opportunities for progression and development.

    Key Responsibilities:

    • Assist global trial manager with the set-up of labs and study vendors as required
    • Perform accompanied visits with CRO CRAs
    • Review of trip reports generated by CRO CRAs
    • Management of CRO and vendors as required
    • Training of junior study managers where required

    Key Requirements:

    • Lead CRA experience or Senior CRA with Lead/Project management experience
    • Vendor management experience
    • Trial monitoring on an International or Global scale
    • Study manager on your own trial(s)
    • Experience in Infectious Diseases would be preferred but not essential
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    Job Title

    Quality Assurance Manager

    Salary: Highly Competitive

    We are looking for a QA Manager to develop and manage a new department within the Quality Assurance unit. The QA manager will report to the VP quality. We are looking for a motivated and dedicated person who will work with the team to develop and strengthen all QA related activities.

    Main responsibilities

    Responsible for management, development and oversight of the quality compliance team
    Maintain process for Legal Compliance in the site by monitoring regulations related to medical device, ISO-standards and corporate regulations
    Responsible for the external audit/inspection program, including hosting and facilitating external audits/inspections
    Qualify as Lead auditor for internal and external audits
    Participate and host external audits/inspection at the site
    Support the site organization with training in the respective quality systems
    External presentation and communication towards customers, authorities and corporate organization in topics related to quality assurance and compliance topics

    Requirements

    Certified as QA Manager
    Experience in similar positions in the Medical Device Industry. This is a must have.
    Excellent ability and high interest in using, managing and developing IT-systems for Quality Assurance
    Experience in ISO 9001, 27001 and 13485 quality systems
    Personnel skills: Proactive, good in cooperation and communication, dedicated and able to motivate the team

    Apply:

    Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact Tahoor Butt on +44 (0) 20 7220 6231